Merck Job Ad
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Merck – with over 300 years of progress and about 38,000 employees in more than 60 countries, we are leading in Pharma, Chemicals and Life
Sciences. With passion, commitment and innovative ideas, we are pursuing a global goal: to improve the quality of life for people. This is why we are looking for you!
Merck Serono, the biopharma­ceutical division of Merck, markets inno­vative pre­scription drugs of chemical and bio­techno­logical origin. It focuses on highly specialized thera­peutic areas such as Neuro­de­ge­ne­rative Diseases, Oncology, Fer­tility, Endo­crinology and Rheumatology.
The Consumer Health Care
division offers high-quality over-the-counter products to enhance the quality of life of consumers all over the world.
The Performance Materials
division offers highly inno­vative materials, advanced techno­logies, and high-tech chemicals. Our market leader products include liquid crys­tals for LCD dis­plays, new lighting techno­logies, and func­tional and effect pigments.
Our Merck Millipore
division offers solutions that enable scien­tists to conduct life science re­search easily, efficiently and eco­nomically. With a range of more than 40,000 pro­ducts, it is one of the top three suppliers of tools to the life science indus­try.
Position Information
Company:
Merck Group
Location:
Darmstadt
Job Category:
Contact Information
Reference Code:
108761
HR Direct Team
+49(0)6151 72-53880
recruiting@merckgroup.com
come2merck.com
Senior Quality Auditing (m/f)
Merck is a global leader in specialized pharma and chemicals, and for almost 350 years we have improved people‘s quality of life. This is due to the creativity and team spirit of our 40,000 employees around the world, so we’re committed to help them develop and to reward their excellence.
Senior Quality Auditing (m/f)
Your role:
Auditing - Scheduling, preparing, conducting and reporting GCP and GVP R&D Quality audits and assessments of research & development operations, both internally and externally to assess the level of compliance with company standards, policies, practices and procedures and current regulations and guidelines. Establish and maintain processes and tools for the preparation, conduct, reporting and follow-up of R&D Q audits.
R&D Quality – Business Related Responsibilities. Assisting in developing global R&D QA strategy and implementing the associated Quality Management System. Participating or leading the preparation and/or review of procedures and guidelines that are used to establish quality requirements, when needed. Providing advice to research & development operations on the interpretation of regulatory GCP and GVP requirements related to quality management, when required. Participating in special assignments on various project teams and workstreams as determined by R&D QA management. Assisting with regulatory inspections or corporate audit activities and external audits (e.g. by business partners) at Merck Serono R&D sponsored or managed activities. Investigating alleged cases of scientific misconduct or fraud. Ensuring rapid communication of QA issues, including potential misconduct with projects/product, to appropriate leaders and colleagues.
Who you are:
University degree in scientific or quality-related subjects. Advanced degree desirable. Equivalent relevant experience maybe considered. Minimum 8 years QA experience or relevant experience in international pharmaceutical and/or biotech industry, in particular clinical, pharmacovigilance, or non-clinical quality management, clinical or non-clinical development, or regulatory compliance with a minimum of 3 years in clinical or non-clinical QA.
Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance and wide range of auditing skills covering a broad range of areas and/or specialized auditing skills in multiple disciplines - including those related to Risk Based Quality Assurance and Data Integrity.
In depth knowledge of drug development process and international GxP e.g. GCP, GLP. GRP, GVP regulations and guidelines
Broad understanding of the drug development process and regulatory environment including specific areas of interest for Merck Serono e.g. oncology, biotherapeutics and emerging markets
Ability to interpret and apply regulations, regulatory guidance, codes and public expectations
Ability to understand detailed scientific information, while remaining anchored in the “Big Picture”.
Demonstrated good interpersonal, communication, organizational, presentation skills, influencing, and problem-solving capabilities.
Ability to adapt to changing direction and needs of the business and can directly apply this knowledge to daily tasks and assignments
Fluency in written and spoken English
What we offer:
Merck‘s portfolio extends from liquid crystals for displays and pigments for automotive coatings to cancer treatments, and your possibilities to develop in our growing company are just as manifold. As a stock-listed company we still make history – not least because we take responsibility for our employees, products, the environment and society. We offer a modern and international working environment to unleash your innovative potential in diverse teams.
Apply now